Back to results

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

Primary Purpose

COVID-19, SARS-CoV-2

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

COVI-VAC

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
Body mass index (BMI) ≤ 35 kg/m2
In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator
Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1

Exclusion Criteria:

Residents of residential care facilities
Pregnant or lactating women
Inadequate venous access for repeated phlebotomy
History of confirmed or suspected SARS-CoV-2 infection

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVI-VAC

Arm Description

COVI-VAC Nose Drops

Outcomes

Primary Outcome Measures

Humoral Immunogenicity

IgG Titer measured by ELISA on day 1

Humoral Immunogenicity

IgG Titer measured by ELISA on day 29

Humoral Immunogenicity

IgG Titer measured by ELISA on day 181

Humoral Immunogenicity measured by neutralizing antibodies

neutralising antibody titer measured by microneutralisation assay in serum on days 1

Humoral Immunogenicity measured by neutralizing antibodies

neutralising antibody titer measured by microneutralisation assay in serum on day 29

Humoral Immunogenicity measured by neutralizing antibodies

neutralising antibody titer measured by microneutralisation assay in serum on day 181

Secondary Outcome Measures

Vaccine and Virus Shedding

SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4

Vaccine and Virus Shedding

SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8

Full Information

NCT ID

NCT05233826

First Posted

February 3, 2022

Last Updated

January 11, 2023

Sponsor

Codagenix, Inc

1. Study Identification

Unique Protocol Identification Number

NCT05233826

Brief Title

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

Official Title

Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Previously Vaccinated Adults Against COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

April 14, 2022 (Actual)

Primary Completion Date

July 21, 2022 (Actual)

Study Completion Date

December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Codagenix, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo. During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, SARS-CoV-2

Keywords

Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COVI-VAC

Arm Type

Experimental

Arm Description

COVI-VAC Nose Drops

Intervention Type

Biological

Intervention Name(s)

COVI-VAC

Intervention Description

Intranasal, live attenuated vaccine against SARS-CoV-2

Primary Outcome Measure Information:

Title

Humoral Immunogenicity

Description

IgG Titer measured by ELISA on day 1

Time Frame

Day 1

Title

Humoral Immunogenicity

Description

IgG Titer measured by ELISA on day 29

Time Frame

Day 1

Title

Humoral Immunogenicity

Description

IgG Titer measured by ELISA on day 181

Time Frame

Day 181

Title

Humoral Immunogenicity measured by neutralizing antibodies

Description

neutralising antibody titer measured by microneutralisation assay in serum on days 1

Time Frame

Day 1

Title

Humoral Immunogenicity measured by neutralizing antibodies

Description

neutralising antibody titer measured by microneutralisation assay in serum on day 29

Time Frame

Day 29

Title

Humoral Immunogenicity measured by neutralizing antibodies

Description

neutralising antibody titer measured by microneutralisation assay in serum on day 181

Time Frame

Day 181

Secondary Outcome Measure Information:

Title

Vaccine and Virus Shedding

Description

SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4

Time Frame

Day 4

Title

Vaccine and Virus Shedding

Description

SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8

Time Frame

Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF Body mass index (BMI) ≤ 35 kg/m2 In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1 Exclusion Criteria: Residents of residential care facilities Pregnant or lactating women Inadequate venous access for repeated phlebotomy History of confirmed or suspected SARS-CoV-2 infection

Facility Information:

Facility Name

HMR

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

We'll reach out to this number within 24 hrs